·         GMP, GAP, Food Safety

·         Sanitary Processes

·         CIP and Aseptic processes

·         Environmental systems for potable water, waste water and clean air

·         HACCP and Preventive Controls

o   Facilitating Development of policy, procedure, training and audits.

o   Conducting audits

·         Food Defense;

o   USDA workshops in Peru and Thailand, with government, academia and industry participants.

o   FDA workshops in the US, Panama and the Caribbean, with over 20 Latin and Caribbean countries.

o   Workshop topics include Vulnerability Assessments, CARVER Plus Shock and Low-Cost Food Defense Measures.

o   Expert Panel member, Institute of Food Technologists (IFT), for FDA review of food sector factors of concern.

o   Industry Workgroup member, National Center for Food Protection and Defense.

·         HACCP “Check-up” of major value added Produce Company

o   Developed a custom and comprehensive inspection tool

o   Inspection of multiple facilities

o   Comparative report with specific recommendations

·         Label Laws; FDA workshop

To drive employee engagement requires accountability and reinforcement.  People must know what is expected of them, and be held accountable, with reinforcement for the right behaviors.


An excellent way to support this is with a Progressive Review of desired behaviors.  To illustrate, a simple Checklist may be performed to determine if desired behaviors are being performed.  If a checklist is all you do until the external audit, you may miss noticing that we might have stopped using the checklist, or it is filled out wrong or behavior still isn’t changing.


To guard against these problems, we institute several progressive steps.  A recurring Review of the checklist should detect gaps in performance or negative trends.  A Self-Assessment compares a personal observation with what is being reported on the checklist. 


Finally, an internal Audit checks the entire program with documentation reviews and observations.  Documentation Reviews insure the checklist is being conducted and reviewed, and insure a response to trends.  Observations look for a correlation with the regular findings on the checklists and self-assessments, allowing for instruction when there is a difference.

We think about traceability with respect to the making of our products, but what about traceability of our compliance program?


When compliance programs are originally written, they at least resemble the regulatory requirement they were based on.  Between errors in the original document and changes over time, there is no guarantee that every requirement remains included in our procedure, and not even any assurance that everything in our procedure is required.

 

Our compliance programs are completely traceable.  Each paragraph of policy, procedure, training, inspections and audit can be traced directly to the related regulatory paragraph.


If a regulatory requirement changes, it is easy to edit only those portions of the policy, procedure, training, inspections and audit that are impacted.  That’s traceability!

Compliance is usually used to describe conformance to some regulatory requirement, but it can also refer conformance to a customer’s specification or requirement.  But mere conformance is transient; on its own it is not sustainable.


In more universal terms, compliance is simply “doing what we say we will do.”  First we must make a commitment to do something, and then we must do it again and again.  This is sustainable compliance.


Our goal in Compliance Management is to provide the knowledge and skills as well as the level of employee engagement to change behaviors.  By permanently changing behaviors we reach sustainable compliance.